Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 4:00 AM
Study NCT ID:
NCT06523166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-15
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE', 'timeFrame': '3 months post procedure'}, {'measure': 'LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE.', 'timeFrame': '3 months post procedure'}, {'measure': 'LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE.', 'timeFrame': '3 months post procedure'}, {'measure': 'Number of detected device-related thrombus (DRT) as measured by CT scan/TEE.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Average size of device measured in millimeters (mm)', 'timeFrame': '3 months'}, {'measure': 'Percent of compression as measured by CT scan/TEE', 'timeFrame': '3 months', 'description': 'Percent compression is comprised by dividing the device diameter over the device size represented as one single score.'}, {'measure': 'Average depth of implant measured in millimeters (mm)', 'timeFrame': '3 months'}, {'measure': 'Average hypo-attenuated thickening (HAT) measured in millimeters (mm)', 'timeFrame': '3 months'}, {'measure': 'Number of adverse events as measured by medical record', 'timeFrame': 'Up to 7 days', 'description': 'Adverse events can include respiratory failure requiring intubation or an esophageal perforation from TEE probe insertion or serious contrast related event including anaphylaxis during the CTA or acute renal failure (ARF) requiring dialysis within 7 days of the CTA.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Watchman FLX', 'Left atrial appendage (LAA)', 'Transesophageal echocardiography (TEE)', 'Cardiac CTA'], 'conditions': ['Device Related Thrombosis', 'Peri-device Leak']}, 'descriptionModule': {'briefSummary': 'The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure.\n\nParticipants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects \\>18 years old planned to undergo LAAC\n* eGFR ≥ 30 mL/min per 1.73 m2\n\nExclusion Criteria:\n\n* Subjects below the age of 18\n* non-English speaking subjects\n* eGFR \\< 30 mL/min per 1.73 m2\n* Subjects with history of contrast allergy\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06523166', 'briefTitle': 'Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study', 'orgStudyIdInfo': {'id': 'STUDY20231491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.', 'description': 'Patients who are status post LAAC using the Watchman FLX.', 'interventionNames': ['Procedure: Transesophageal echocardiography (TEE)', 'Procedure: Cardiac CTA']}], 'interventions': [{'name': 'Transesophageal echocardiography (TEE)', 'type': 'PROCEDURE', 'description': 'TEE will be performed using a 3D probe. TEE images will be acquired at the standard 0, 45, 90, and 135 degree views along with a 3D acquisition encompassing the entire LAA, device, left pulmonary vein and lateral mitral annular landmarks.', 'armGroupLabels': ['Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.']}, {'name': 'Cardiac CTA', 'type': 'PROCEDURE', 'description': 'Cardiac CTA will be performed with ECG gating using systems with ≥ 64 detector rows and with temporal resolution that is at least 175 msec (rotation speed ≤ 350 msec for single source systems). Cardiac CTA images will be acquired for the entire cardiac cycle without ECG phase specific pulsing and with contrast appropriately timed for peak left atrial/arterial phase contrast enhancement. In addition, a targeted end systolic only delayed phase image set (45 seconds after the arterial phase scan and limited to the left atrium and appendage device) will be acquired.', 'armGroupLabels': ['Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Rhona Littman', 'role': 'CONTACT', 'email': '*Littmanr@cshs.org', 'phone': '310-423-4387'}, {'name': 'John Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars Sinai', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Haag, RN, MPA', 'role': 'CONTACT', 'email': 'Elizabeth.Hagg@chsli.org', 'phone': '516-622-4512'}, {'name': 'Omar Khlaique, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Francis Hospital and Catholic Health', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Dana Amaro, MSN, RN', 'role': 'CONTACT', 'email': 'Dana.Amaro@atriumhealth.org', 'phone': '704-355-4692'}, {'name': 'Markus Scherer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sanger Heart & Vascular Institute- Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Amy McKnight, RN, BSN, BCCV', 'role': 'CONTACT', 'email': 'Amy.McKnight@UHhospitals.org', 'phone': '216-983-4896'}, {'name': 'Steven Filby, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Adrianne Miller, MS, CCRP', 'role': 'CONTACT', 'email': 'Adrianne.Miller3@osumc.edu', 'phone': '614-688-8252'}, {'name': 'Mahmoud Houmssee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Amy McKnight, RN, BSN, BCCV', 'role': 'CONTACT', 'email': 'Amy.McKnight@UHhospitals.org', 'phone': '216-983-4896'}], 'overallOfficials': [{'name': 'Steven Filby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, Interventional Cardiology', 'investigatorFullName': 'Steven Filby, MD', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}